Safety and Tolerability of Long-Term Administration of OROS Hydromorphone HCI (Slow Release) in Cancer Pain
Information source: Alza Corporation, DE, USA
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Analgesics, Opioid
Intervention: OROS hydromorphone HCI (slow release) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alza Corporation, DE, USA Official(s) and/or principal investigator(s):
Alza Corporation Clinical Trial, Study Director, Affiliation: Alza Corporation, DE, USA
Summary
The primary purpose of this study was to characterize the pain control achieved with
long-term repeated dosing of OROS hydromorphone (slow release) in patients with chronic
cancer pain and the secondary purpose was to characterize the effects of pain on the
patients' quality of life with long-term, repeated dosing of OROS hydromorphone (slow
release) taken by patients with chronic cancer pain.
Clinical Details
Official title: Safety and Tolerability of Long-Term Administration of Dilaudid SR (Hydromorphone HCI) in Cancer Pain
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Study results indicated that long-term treatment with OROS hydromorphone can be useful in the management of persistent, moderate-to-severe chronic pain in patients with cancer
Detailed description:
Study DO-118X was a phase-3, multicenter, open-label extension study in adult patients with
cancer pain who had successfully completed Study DO-118 with dose-stable pain control taking
at least 8 mg of OROS hydromorphone (slow release) or its equivalent morphine sulfate SR
(slow release) dosage. Patients were started on the dose of OROS hydromorphone equivalent to
the opioid dose on which they had achieved dose-stable pain control in the SR (slow release)
phase of Study DO-118. Patients returned to their study clinic once a month for 1 year.
Dosage adjustments to study medications and breakthrough pain medication were permitted.
OROS hydromorphone HCI (slow release) tablets in 8, 16, 32 and 64mg doses administered orally
every 24 hours
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who have chronic cancer pain, and who have successfully completed the OROS
hydromorphone SR (slow release) study, DO-118
- Patients must have been in dose-stable pain control in the last two days of the slow
release phase of the study
- Patients who require at least 8mg of OROS hydromorphone slow release every 24 hours
for the management of chronic cancer pain
Exclusion Criteria:
- Pain which is not considered to be potentially responsive to opioids
- Gastrointestinal disease of sufficient severity to be likely to interfere with oral
analgesia including: dysphagia, vomiting, no bowel movement or bowel obstruction due
to impaction within the 5 days prior to the start of the trial, severe gut narrowing
that may affect the absorption or transit of orally administered drugs, particularly
the insoluble OROS outer coating
- Any patient in whom the risks of treatment with hydromorphone outweigh the potential
benefits. Such risk categories include: raised intracranial pressure, hypotension,
hypothyroidism, asthma, reduced respiratory reserve, prostatic hypertrophy, hepatic
impairment, renal impairment, elderly and debilitated, convulsive disorders and
Addison's disease
Locations and Contacts
Additional Information
Ending date: April 2002
Last updated: April 17, 2008
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